India's vaccine industry has been facing a stormy
weather due to the World Health Organization's (WHO) decision to go slow on
products made in the country. This was because the government laboratories on
which the Indian regulator, the Drug Controller General of India (DCGI), relied
for tests had outdated facilities and were forced to shut down over quality
issues. The three vaccine manufacturing plants in the public sector are located
at the Central Research Institute (CRI), Kasauli, Himachal Pradesh, BIBCOL,
Bulandshahr, Uttar Pradesh, and King's Institute, Chennai.

The vaccine industry's cries over this
"quality" issue threatening their export orders have been finally
heard. The regulator has recommended a quick remedial action which can help
remove the dark clouds hanging over the Rs 1,900 crore Indian vaccine industry.

The regulator has recommended to the Ministry of Health to
set up new GMP (Good Manufacturing Practices) compliant, global standards
manufacturing plants urgently to resume production of vaccines in the government
sector in the country.

Excerpts from a media interaction with the Drug Controller
General of India, Dr Surinder Singh, during the 6th Pharma Summit, organized by
the Confederation of Indian Industry (CII) in Mumbai in mid-September

Is the government going to modernize the
three vaccine plants which have been shut down over quality issues?

We have submitted a report to the Ministry of Health on this
issue and it has concluded that the three facilities did not follow GMP and they
cannot be modernized and made GMP compliant because these are very old
institutions. Some of these institutions were set up over 100 years ago.

So what is the way out?

We have recommended that the essential vaccines which were
made in these plants should continue to be manufactured in the country but not
in these facilities but in new state-of the-art GMP-compliant facilities.

What happens to the highly qualified
technical personnel who were employed in the shut down facilities?

We have to make the best use of the trained human resources
available in the existing facilities. We have recommended granting approval to
start the production of some important products like the yellow fever vaccine.
Rabies tissue culture vaccines, seasonal influenza vaccine (because of reasons
pertaining to national security) and typhoid vaccines. The new facilities could
also increase the production of anti-serum, which is in short supply now.

Are you going to increase the number of
people at these plants?

The Kasauli institution is looking at increasing the
technical personnel from 40 to 150. The number could even go up to 200. This is
because the country will require about 5,500 batches of these essential vaccines
to be made here in a year.

Will there be a shortage of vaccines in
the country?

Every year the country makes vaccines worth Rs 1,900 crore.
Out of this, the domestic sales figure is only about Rs 400 crore and the
remaining Rs 1,500 crore is exported. Every third child in the world is
immunized with measles vaccine made in India. Around 70 percent of the global
supplies of this vaccine are from India. In fact, India had exported about 80
million doses of measles vaccine to Pakistan recently. There is no shortage of
vaccine for the public health system in the country. There could, however, be
some issues relating to timely procurement.

Vaccine industry has been complaining
about the low prices given to them during procurement. What is the reality?

Pricing is not at all an issue. For example, an institute
with the best GMP facilities manufacturing BCG vaccines would export it at a
price of Rs 40 to foreign countries whereas to the Government of India it will
be sold at a price of Rs 17.

Is the country improving the regulatory
standards?

This is something we are working on. We are at present
collaborating with the WHO for training activities and with the USFDA and Health
Canada for other aspects. Vaccine manufacturers can now submit their revamp
plans electronically. We are also introducing various e-Governance measures to
bring reliability, accountability and adherence to timelines. Proposed
initiatives include setting up LAN/WAN connectivity of CDSCO campus, online
submission of all forms, digitalized interactive portal, digitalization of
records and online approvals with digital sign.